Modernizing Perinatal Syphilis Testing

Overview

The purpose of this study is to determine the testing performance of real-time quantitative polymerase chain reaction and transcription mediated amplification by comparing test performance of these novel molecular tests to current 2021 CDC CS guidelines for maternal/neonatal dyads at risk for syphilis infection and to determine whether CS is associated with adverse neurodevelopmental outcomes.

Interventions

• Diagnostic test Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum
  A quantitative polymerase chain reaction (qPCR) assay detects and quantifies DNA in a sample, and the qPCR assay used in this study targets the polA gene of T. pallidum to confirm presence of T. pallidum in a sample. Samples will be collected from the mother/newborn dyad at the time of birth. qPCR data will only be used to determine testing performance and will not be used in clinical management of study participants.
• Diagnostic test Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum
  The Aptima transcription-mediated amplification (TMA) assay used in this study will target RNA of T. pallidum to confirm presence of T. pallidum in a sample. Samples will be collected from the mother/newborn dyad at the time of birth. TMA data will only be used to determine testing performance and will not be used in clinical management of study participants.
• Other Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis
  Using the Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines, new born syphilis infection is categorized by clinical providers at birth as follows: confirmed proven/highly probably, possible congenital syphilis (CS), CS less likely, or CS unlikely. These CS categories are determined using neonatal nontreponemal test results, physical exam of the infant, placental pathology, and maternal serologies and treatment history, and comparison of maternal and

Primary outcome measures

• Sensitivity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum [Time frame: from the time of birth up to 96 hours after birth]
• Specificity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum [Time frame: from the time of birth up to 72 hours after birth]
• Positive predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum [Time frame: from the time of birth up to 72 hours after birth]
• Negative predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum [Time frame: from the time of birth up to 72 hours after birth]
• Area under the receiver operating characteristic (ROC) curve of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum [Time frame: from the time of birth up to 72 hours after birth]
• Sensitivity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum [Time frame: from the time of birth up to 72 hours after birth]
• Specificity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum [Time frame: from the time of birth up to 72 hours after birth]
• Positive predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum [Time frame: from the time of birth up to 72 hours after birth]
• Negative predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum [Time frame: from the time of birth up to 72 hours after birth]
• Area under the receiver operating characteristic (ROC) curve of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum [Time frame: from the time of birth up to 72 hours after birth]

Eligibility criteria

Inclusion criteria

• Maternal diagnosis of syphilis by 2021 CDC STI guidelines, irrespective of treatment status; AND viable pregnancy with gestational age ≥ 12 weeks OR postpartum ≤ 96 hours from delivery OR Neonates of pregnancies affected by syphilis ≤ 72 hours of birth
• Individuals (men and non-pregnant) with syphilis in Harris Health clinic with syphilis

Exclusion criteria

• Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive)
• Planning to move outside of study prior to ND testing

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 9 centers

• University of Southern California — Los Angeles
• University of California, Los Angeles — Los Angeles
• Johns Hopkins University — Baltimore
• Kennedy Krieger Institute — Baltimore
• Nationwide Children's Hospital — Columbus
• Baylor College of Medicine — Houston
• Texas Children's Hospital — Houston
• The University of Texas Health Science Center at Houston — Houston
• … and 1 more center

Identifiers

NCT: NCT06082453 · HSC-MS-21-0731 · R01HD108201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗